N=~180
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the J&J Clinical Trial Finder
Key eligibility criteria*:
For participants with relapsed or refractory MM:
- Initial diagnosis of MM according to IMWG diagnostic criteria
- Relapsed or refractory MM with prior treatment including a PI, IMiD agent, and anti-CD38–based therapy
- Measurable disease at screening
- ECOG PS 0–1
- No prior allogeneic transplant within 6 months or autologous transplant within 12 weeks
For participants with previously treated AL amyloidosis:
- Initial histopathological diagnosis of amyloidosis
- Not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received ≥3 cycles of 1 prior line of therapy or a total of ≥2 cycles of >2 prior lines of therapy for AL amyloidosis
- Measurable disease at screening defined by ≥1 of the following:
- Serum iFLC ≥50 mg/L or dFLC ≥50 mg/L, or
- Serum M protein ≥0.5 g/dL
- ≥1 organs impacted by systemic AL amyloidosis
- LVEF ≥45%
Primary outcomes:
Part 1
- DLTs
Parts 1 and 2
- AEs by severity
Part 2
- Abnormalities in laboratory values
Secondary outcomes:
- Serum concentration of JNJ-79635322
- ADAs to JNJ-79635322
- Preliminary anticancer activity of JNJ-79635322
- TTR
- DOR
*Not a complete list of inclusion and exclusion criteria.
Ab, antibody; ADA, antidrug antibody; AE, adverse event; AL, amyloid light chain; BCMA, B-cell maturation antigen; CD, cluster of differentiation; dFLC, difference between involved and uninvolved free light chain; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GPRC5D, G protein–coupled receptor class C group 5 member D; iFLC, involved free light chain; IMiD, immunomodulatory drug; IMWG, International Myeloma Working Group; LVEF, left ventricular ejection fraction; MM, multiple myeloma; PI, proteasome inhibitor; SC, subcutaneous; TTR, time to response.